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EU companies can export generic versions of patented drugs to poor countries

Brussels Rory Watson

The European Union has adopted legislation that will allow companies to produce copies of patented medicines, under licence, for export to developing countries. The measures will allow poor nations that lack or have insufficient drug manufacturing capacity, to import safe and effective generic medicines.

The initiative follows the move last December by the Geneva based World Trade Organisation (WTO) to make permanent an earlier provisional waiver to the trade related aspects of intellectual property rights (TRIPS) agreement.

This amends the existing rules on intellectual property, which state that compulsory licences can only be authorised predominantly for supplies to the domestic market. Removing the obligation allows WTO members to export generic medicines provided certain conditions in both the exporting and importing countries are met.

Supporters of the amendment believe that it will make it easier for companies in rich countries to make drugs to tackle health problems such as AIDS, malaria, and tuberculosis at prices that the globe’s poorest countries can afford.

Peter Mandelson, the EU’s trade commissioner, said, “This is an important EU contribution to the fight against killer diseases in developing countries. It shows that the EU is committed to ensuring that the WTO system can respond to the public health concerns of poor countries in need of affordable medicines.”

The EU legislation, which was designed to ensure uniform rules for all 25 member countries instead of a patchwork of different national measures, goes further than the original WTO decision by extending the new system to any developing country, not limiting it to members of the WTO.

There is no restricted list of drugs that may be produced and exported, as exists in Canada. The legislation bans reimportation of the drugs into Europe. Customs authorities can confiscate any medicines caught breaking the embargo, and abuses can lead to a licence being revoked.

Despite the existence of the specially tailored legal framework, non-governmental organisations and generic medicine manufacturers are sceptical about its ability to deliver cheap drugs in practice.

Médecins Sans Frontières, which has strongly campaigned for concrete action to help the world’s poorest countries, believes that the current measures are too complex and cumbersome. Pointing to Canada, which has had a similar system in place since 2003, a spokeswoman pointed out that this had still not led to the export of any generic drugs. “We want something for developing countries, but we do not feel the EU is going about it the right way. It should perhaps have looked at the possibility of giving incentives to the generic industry,” she said.

The response of the European Generic Medicines Association was also lukewarm. A spokeswoman described its view as “neutral, very cautious, and not excited.” Although individual companies were looking at the possibilities involved, she stressed that they were “very busy” on the European market.